AMT Mini ONE® Extension Set 8-2455Recalls & reported problems
Applied Medical Technology, Inc. · 24" Mini ONE® RIGHT ANGLE Feeding Set with Y-PORT (Box 10) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842071109028), received between May 26, 2021 and May 26, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 other recall cover devices cleared under the same FDA submission (K142989, K971757); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2021Detachment of Device or Device Component
THIS REPORT IS IN RESPONSE TO INITIAL REPORT #MW5100424, WHICH PROVIDED THAT THE MINI ONE 24" RIGHT ANGLE FEEDING SET WITH Y-PORT Y PORT SEPARATED FROM TUBING WHEN DISCONNECTING SYRINGE FROM Y PORT. NO OBVIOUS CUTS OR DAMAGE SEEN TO NAKED EYE. PATIENT NOT HARMED. GASTRIC CONTENTS EMPTIED INTO BED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11890598 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K142989, K971757. One submission often covers many models, so check the product and lot details in each record.
- Z-0819-2025 · Nov 26, 2024 · CompletedAMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
Other Gastrointestinal Tubes With Enteral Specific Connectors devices
- EndoVive Safety PEG Kit M00509000Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall32 reports
- EndoVive Safety PEG Kit M00509010Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall16 reports
- EndoVive Standard PEG Kit M00509050Boston Scientific Corporation · Gastrointestinal Tubes with Enteral Specific Connectors1 recall6 reports
- Salem Sump 8888264986ECardinal Health 200, LLC · Gastrointestinal Tubes with Enteral Specific Connectors1 recall1 death2 reports
- Salem Sump 8888268060ECardinal Health 200, LLC · Gastrointestinal Tubes with Enteral Specific Connectors1 recall0 reports
- Salem Sump 7771810ECardinal Health, Inc. · Gastrointestinal Tubes with Enteral Specific Connectors28 reports
- Salem Sump 7771610ECardinal Health, Inc. · Gastrointestinal Tubes with Enteral Specific Connectors1 death18 reports
- Edi Catheter ENFit 6Fr/49 cm, 5pcs 6883898Maquet Critical Care AB · Gastrointestinal Tubes With Enteral Specific Connectors14 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.